Kala Pharmaceuticals announced that the first patient has been dosed in STRIDE 3 (Short Term Relief In Dry Eye), its phase 3 trial of KPI-121 0.25% for the short-term treatment of dry eye disease.
“We are pleased to initiate the STRIDE 3 trial of KPI-121 0.25%. If approved, KPI-121 0.25% could be the first FDA-approved product for the short-term treatment of dry eye disease,” Kim Brazzell, Chief Medical Officer, said in a company news release. “The STRIDE 3 trial design reflects specific modifications to the inclusion/exclusion criteria of our previous trials to address key factors which we believe will improve the probability of success. We anticipate reporting topline results in the fourth quarter of 2019. We also continue to prepare for the potential approval and launch of INVELTYS (KPI-121 1%), which has been granted a target action date under the Prescription Drug User Fee Act (PDUFA) of August 24, 2018, and which, if approved, is expected to be the first twice-daily ocular corticosteroid indicated for the treatment of post-operative ocular inflammation and pain.”
STRIDE 3 Phase 3 Trial Design
The STRIDE 3 trial is a multicenter, randomized, double-blind, placebo controlled, parallel-arm study comparing KPI-121 0.25% to placebo, each dosed four times a day (QID) for 14 days, in approximately 900 patients with dry eye disease. Subjects who meet initial screening and inclusion/exclusion criteria undergo a 2-week run-in period with placebo. Subjects who continue to meet inclusion/exclusion criteria after the run-in are randomized to either KPI-121 0.25% or placebo. The primary endpoint, Day 15 ocular discomfort severity, is based upon a patient diary in which ocular discomfort is recorded daily over the entire course of the trial using a visual analog grading scale. Topline data from this study is expected in the fourth quarter of 2019.
About the KPI-121 0.25% Development Plan
In January 2018, Kala announced topline results for two phase 3 trials (STRIDE 1 and STRIDE 2), evaluating the safety and efficacy of KPI-121 0.25% versus placebo in patients with dry eye disease. KPI-121 0.25% achieved statistical significance for the primary sign endpoint of conjunctival hyperemia at Day 15 in the intent to treat (ITT) population in both Phase 3 trials. KPI-121 0.25% also achieved statistical significance for the primary symptom endpoint of ocular discomfort severity at Day 15 in the ITT population in STRIDE 1 with a trend towards a treatment effect in STRIDE 2. Statistical significance was achieved in STRIDE 1 for the second primary symptom endpoint of ocular discomfort severity at Day 15 in patients with a more severe baseline discomfort, with a strong trend towards a treatment effect observed for the same endpoint in STRIDE 2. Positive treatment effects were also observed in both trials for the symptom endpoint of ocular discomfort severity in the ITT population at Day 8, which was a key pre-specified secondary endpoint. KPI-121 0.25% was well-tolerated in both Phase 3 trials with elevation in intra-ocular pressure, a known side effect with topical corticosteroids, similar to placebo.
Kala plans to file a new drug application (NDA) with the FDA during the second half of 2018. The NDA will include data from three clinical trials studying approximately 2000 patients, including one Phase 2 trial and two Phase 3 efficacy and safety trials. In addition, based upon the recommendation of the FDA, Kala has initiated the STRIDE 3 Phase 3 clinical trial evaluating KPI-121 0.25% for the temporary relief of the signs and symptoms of dry eye disease.